Regulatory Affairs Specialist

We anticipate the application window for this opening will close on - 3 Nov 2026   Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Regulatory Affairs Specialist supports international regulatory strategies and submission activities across global markets. This role is responsible for assisting with new product registrations, renewals, amendments, and other country-specific regulatory requirements to help ensure compliance and maintain market access. The Regulatory Affairs Specialist works closely with regional regulatory colleagues and cross-functional teams, including Quality, Clinical, Manufacturing, and Marketing, to support submission readiness, coordinate documentation, and contribute to timely execution. This is an on-site position and may be based in North Haven, CT; Lafayette, CO; Mansfield, MS; or Mounds View, MN. The role supports global submissions across Asia Pacific, the Middle East and Africa, Latin America, Canada, and EMEA, while helping track timelines, identify submission risks, respond to health authority questions, and support the lifecycle management of regulated products                     Responsibilities may include the following and other duties may be assigned. • Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections. • Compile materials required for global submissions, license renewals, amendments, and responses to health authority inquiries. • Assess regulatory requirements and help recommend appropriate submission strategies based on business needs, risk, and timelines. • Support critical, complex, and time-sensitive registrations while balancing compliance and operational priorities. • Review regulatory, technical, quality, labeling, and product documentation for completeness, accuracy, and consistency. • Manage multiple projects simultaneously while tracking deadlines, action items, and submission status to support timely execution. • Identify regulatory risks, gaps, and delays early and escalate issues as needed to support resolution. • Communicate regulatory requirements clearly to internal and external stakeholders to support informed decision-making. • Stay current with regulatory procedures, guidelines, and changes in global requirements. • Apply sound judgment to support regulatory activities, collaborate with stakeholders, and assist team members as needed. • Maintain awareness of evolving global regulatory requirements and communicate relevant updates to internal teams. • Support continuous improvement by identifying opportunities to streamline submission processes, trackers, and cross-functional ways of working. Must Have: Minimum Requirements • Bachelor’s degree required • Minimum of 2years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience.   Nice to Have • Experience with U.S. FDA and international regulatory requirements for medical devices • Familiarity with EU MDR, MDD, ISO 13485, ISO 14971, and related standards • Experience supporting regulatory submissions, audits, or inspections • Strong written and verbal communication skills • Strong organizational skills with the ability to manage multiple priorities • Experience collaborating in a cross-functional, fast-paced environment • Familiarity with medical device product development or lifecyc